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Genetic Modification Summit - Marian Hobbs Speech

Hon Marian Hobbs
27 November 2001 Speech Notes

Genetic Modification Summit: The Government’s response to the recommendations of the report from the Royal Commission on Genetic Modification, Duxton Hotel 9.10am Tuesday Nov 27

Earlier this month, the Government announced its detailed decisions on the report and recommendations of the Royal Commission on Genetic Modification. Today, I want to talk to you about our decisions, and to outline next steps. There are two matters in particular that I will focus on during the course of my talk:

- First, why we decided to introduce legislation to restrain applications to release genetically modified organisms, and

- Second, the compliance cost implications of the Government’s decisions.

The response process

I do not propose to go over the report of the Royal Commission on Genetic Modification in any detail. I’m presuming you are among those who actually read the report and, as I see from the programme, Dr Jean Fleming, one of the Commissioners, addressed you all yesterday.

What I will do, however, is to talk briefly about the process that was followed to respond to the report.

As Minister for the Environment, I have been responsible for setting up the Royal Commission, monitoring its progress and reporting to Cabinet with recommendations for responding to it. When it came to the Government’s response, we deliberately set up a group of officials from across a broad range of agencies to look at the report in detail and provide advice to enable the Government to decide on the way forward. In line with my role, the Ministry for the Environment coordinated this work at the departmental end.

Let me emphasise this point, although environment issues are significant in this debate, this did not mean that environment issues predominated. The response to the Royal Commission’s report is from the Government as a whole. To achieve this whole-of-government approach, working closely with the Ministry for the Environment was a core group of officials comprising:

- Ministry of Agriculture and Forestry

- Ministry of Economic Development

- Ministry of Foreign Affairs and Trade

- Ministry of Health

- Ministry of Research, Science and Technology

- Te Puni Kokiri - Ministry of Maori Development

- The Treasury, and

- The Department of Prime Minister and Cabinet.

Others included Customs, the Department of Conservation, and the Ministries of Consumer Affairs, Fisheries and Justice. Crown agencies were also involved, including in particular the Environmental Risk Management Authority and the Foundation for Research, Science and Technology. And last but not least, officials read and listened in various forums to the views of a wide spectrum of stakeholders. These views were taken into account in the response process.

How the Government responded

The Government quite deliberately set out to respond to the report in three phases. Because of the high public interest and divergence of views, the first step was to release the report as soon as practicable.

At that time, as many of you will recall, we commented on the report in general. We commented that the inquiry is the most wide-ranging into genetic modification undertaken in any country, and we thanked the Commission for the balanced and thorough report it produced. The Government had deliberately set up the Royal Commission with a brief for wide public consultation, and it was clear that the Commission had achieved a broad scale of consultation and provided a highly readable report. At that time I said - and despite the rapid developments in this area I still believe this - the report is a valuable tool in the continuing public discussion on genetic modification.

We also said that we’d be looking carefully at the report and recommendations before making any decisions about the future application of genetic technologies. Put another way, we made it clear that the Government’s response would be considered and measured. However, we did offer an indication of the key issues that would inform the detailed decisions that were yet to come. We flagged the Government’s commitment to a more dynamic economy driven by education, innovation, research and technology. We also stated that we would not allow the health and safety of New Zealanders to be compromised in pursuit of that. As well as weighing up the economic and social benefits and the risks of genetic modification, we stated we’d have regard to the cultural, ethical, environmental and international implications of genetic modification.

So right from the beginning, we have been clear about the context within which we’d be making our decisions. This context clearly includes both looking after the health and safety of New Zealanders and of our environment and the development of our economy.

The Government’s key decisions

The second phase of the Government’s response to the Royal Commission’s report was our announcement of key decisions. The major theme of the Royal Commission's report is “preserving opportunities”. The Commission thought it unwise for New Zealand to turn its back on the potential advantages on offer from genetic modification, but - and this is important - recommended that New Zealand proceed carefully and implement genetic modification cautiously, minimising and managing risks.

The Government’s conclusion is to accept this overall strategy of preserving opportunities. This should come as no surprise. Why would we not want to preserve opportunities? Opportunities to develop New Zealand’s major businesses, improve our healthcare, and advance our knowledge and understanding of biological systems, including our biodiversity, and our environment would have been lost or threatened if we’d taken one of the two extremes. These extremes were of course:

- Either accepting genetic modification without safeguards and the related compliance costs, or alternatively

- Rejecting genetic modification despite the actual and potential benefits it can offer.

At the heart of this key decision is concern about the health and safety of all New Zealanders and our environment. Because genetic modification is a relatively new technology, we need to ensure we are cautionary about how New Zealand proceeds. Our decision is a balanced one. It means that extra steps will be taken to protect our health and environment, but it also recognises the need to have knowledge and innovation drive our future as a nation. It also enables responsible science to continue to play a key role in the development of New Zealand into the 21st Century.

However, we have come to some different conclusions from the Royal Commission as to how the overall strategy of preserving opportunities should best be implemented. The differences are in two main areas:

- The first is the extent to which commercial use or release of live genetically modified organisms (or GMOs) should be possible in the immediate future.

- The second area is the conditions under which contained field testing of GMOs should be able to proceed.

A constraint period on the release of GMOs

The Government believes that there should be no releases of GMOs until changes are made to the Hazardous Substances and New Organisms Act, and analysis and research identified as necessary by the Royal Commission are done.

As I’m sure you’re all aware, under the law as it stands, any proposal to “release” a GMO in our country, requires an application to the Environmental Risk Management Authority. The Authority would carefully assess the application to release the GMO, and only if it decided that it is safe in terms of public health and the environment could it be used or released in New Zealand. Importantly, if this approval were granted, the law only allows for approval to be given to the GMO without environmental controls.

There have so far been no applications under the HSNO Act for release of GMOs in New Zealand.

We are not expecting any applications to be made to ERMA to release GMOs in the near future, especially for genetically modified crops. However, we don’t want to wait around until that first application is made before deciding how to act. We want to be absolutely certain that no applications are made and considered while we do some of the detailed work recommended by the Royal Commission. This includes looking into the economic implications and safety of GMOs generally, and making enhancements to the HSNO Act. We are therefore rejecting the Royal Commission’s recommendation that the Government decide now that I will call in the first application to release a GM crop. Apart from not being able to make such a decision in the absence of such an application, we did not think it was the right response given the work that needs to go ahead.

The Government will shortly introduce a bill to put in place a two-year restricted period during which time no applications can be processed by ERMA to release GMOs.

Exception - human and animal health benefits

There is an important exception, however. Applications to release GMOs that will give direct benefits to human health or animal health, or that are to deal with a serious emergency will be able to go ahead. What this means is that if someone wants to introduce an effective medicine that is also a live GMO - a vaccine for example - then an application can be made to the Authority to have that medicine assessed and considered for use in New Zealand. The Authority’s assessment would look at the environmental risks. Under the Medicines Act, Medsafe, the normal regulator for all medicines, would also assess the medicine in terms of its effectiveness and safety for humans.

Let me emphasise that last point, such a medicine would need to be considered in the light of both its environmental risks and its safety as a medicine. This again reflects the need to be cautious with this new technology. Under the proposed bill, if someone made an application to ERMA to release a GMO medicine, the exemption will also require that:

- Applicants provide additional information demonstrating that the GMO medicine cannot persist viably in the physical environment beyond the human or animal being treated with the medicine (in other words, even if it got out into the environment it would die off).

- ERMA take account of safety, ecological effects and relative efficacy. That is, ERMA would compare the efficacy of the medicine against alternative medicines in New Zealand.

Similar provisions apply to animal vaccines. The emergency provisions to approve a GMO remain unchanged.

Changes to contained field testing

So that is the first important change we are making to the current law. The second area that’s being covered in the bill concerns enhancing the way in which contained research is controlled.

Before moving onto the changes that will be made to the HSNO Act in this area, I want to talk to you about what exactly this contained research is.

First of all, contained research involving genetically modified organisms is not new to New Zealand. It has been going on since the mid 1980s. Initially it was done under a voluntary control regime, but for the last three years the research has been controlled and monitored under the HSNO Act. So contained research is not new in New Zealand and furthermore, all the evidence we have is that it has and continues to be just that, fully contained.

The second point I want to make is that there are two types of contained activities:

- Developments undertaken inside a secured laboratory, and

- Contained field testing.

There is a lot of confusion about the latter, and this is not helped by the various names it is given. This work has been given the name “field trials” in the media and the HSNO Act uses (and carefully defines) the term field testing. In some cases I’ve even heard people talk about “field releases”, a most ambiguous and misleading phrase.

As I’m sure most of you are aware, contained field testing is not large areas of GM crops waving around in farm-like fields, spreading pollen, seeds etc into the wider environment. This confusion seems to come from some other countries where field trials are done in this way or from our own trials of different crops - not GM crops. The reality is that under our laws field testing involving GM is generally a type of research activity that takes place where the organism (plant or animal) is exposed to the environment but under very strict conditions that ensure that the GMO cannot escape. In order to have this happen field test areas are generally quite small. The sorts of controls that are placed on these field tests include:

- Destroying or enclosing the reproductive parts of plants, e.g. removing flowers before pollen forms.

- Restricting access to the containment facility, so unauthorised people cannot carry away any reproductive material, and risk spreading the GMO beyond the research site.

- Excluding animals from the facility, so that they cannot accidentally remove reproductive or other material from the research site.

- High security fences special tagging systems for animals.

Controls are regularly inspected both during the research and sites are always checked for long periods after it is complete to make doubly sure there is nothing left.

If you’re interested, details of these controls can be read on ERMA’s website (www.ermanz.govt.nz).

Genetically modified pine trees

To get an understanding of this, let’s look at an example of how a real field test is controlled. There is a field test of genetically modified pine trees that has been approved and in this case the controls can be summarised as:

- Trees that are taken from the secured laboratory for the field test are counted, and then counted again when they are planted in the contained field.

- There are limits on the total number of trees allowed to be planted over the entire approval period (in the case I am describing it’s a total of 330 over the entire trial).

- Plants must be transported from the secured laboratory to the field test site in packages that are closed and non-crushable.

- Most trees have to be destroyed at a maximum age of 6 years or sooner if reproductive structures (e.g. pine cones) start to grow.

- There are strict controls on the trees that are allowed to grow beyond this stage - all male cones have to be removed as soon as they are detected; and only up to 10 female cones can remain on a tree until they reach a certain growth stage.

- All these reproductive structures removed from the trees must be transported in secure containment back to the secured laboratory or destroyed. Trees no longer required for the research also have to be transported and destroyed in a similar manner.

- To keep unwanted people and organisms from the trial site, it is fenced and a record must be kept of all people with access to the site.

I hope you can see from this example that field testing is at present strictly contained and monitored.

This example also, I think, illustrates the Royal Commission's conclusion that the regulatory framework governing research involving genetic modification is sound. It concluded that the case-by-case approach taken by ERMA under the HSNO Act, supported by the range of containment provisions, provides a strict and rigorous regime. I would also point out that under this regime deciding on whether or not to have a field test allows for public input, and requires consideration be given to the principles of the Treaty of Waitangi. ERMA must also consider the need for caution where there is scientific and technical uncertainty.

However when we looked at this system as it is written into law, we found that at present ERMA has some discretion to determine all the conditions to be applied to approved research. I would have to say that ERMA has always exercised that discretion in a way that has led to high security on the 6 field tests currently in progress in New Zealand.

However, as an added safety measure, the Government has decided make it absolutely clear that all research must meet the strictest safety (or containment) standards. The HSNO Act will be amended to require specific mandatory conditions to be applied to any future field test approval.

This will include explicit conditions on contained field tests of genetically modified plants and animals to ensure that:

- For plants, all heritable material above or below the ground is strictly contained, and

- Any animals involved in field tests, including their offspring, must be held in secure containment and clearly identified so it can be easily identified and retrieved if it escapes.

In addition to this we will be requiring a strict and compulsory inspection programme for each field test.

In short, we already have the strictest controls in the world for contained research and, through this bill being developed, we are making them stronger.

Although these law changes require time to be made, the changes will be effective as of 29 October, which is when the Government announced these decisions. Although the restricted period expires in October 2003, the changes to approved field test controls will be a permanent feature of the HSNO Act so will continue beyond the restricted period.

Anyone wishing to make an application to ERMA will do so in the knowledge that these additional measures are effective from the end of October. It’s important for the law change to occur as soon as possible so that all of us are clear about what applications can and cannot be made, what the possible exemptions are (such as for GMO vaccines), and what additional controls will be placed on contained field tests.

Work over the 2-year timeframe

So what will the Government be doing over the next two years, while the restricted period is in place? There are a number of important things all aimed at enhancing the system for controlling genetic modification and getting better information about it. The main pieces of work are to:

- Carry out essential research, recommended by the Royal Commission, to understand better the issues involved in managing GM, if we were to go down that road; for example marketing and soil ecology.

- The Government will explore coexistence and conditional release frameworks as far as is practicable in the absence of releases.

- Put in place many of the amendments to the HSNO Act, which the Royal Commission recommended. This includes the legal parts of the conditional release framework, and importantly streamlining of the system for approving work in secured laboratories.

- Establish Toi te Taiao or the Bioethics Council to advise, provide guidelines and promote dialogue on the cultural, ethical and spiritual issues associated with biotechnology.

- Further investigate the liability system for genetic modification related issues. Specifically the Government will be looking at how to include this in the Law Commission's work programme. This will ensure that any potential problems with the existing liability system are identified and addressed proactively, and more importantly visibly and transparently.

- Develop a biotechnology strategy. The strategy will ensure that New Zealand keeps abreast of developments in biotechnology, with a mechanism to ensure ongoing balance between benefits and risks. On the other hand some of you may be aware that the Royal Commission recommended the setting up of a Parliamentary Commissioner for Biotechnology: We do not intend to do this although we do think that some of the tasks envisaged for the Commissioner are useful and we will be considering other ways to do these.

Detailed decisions

As most of your will be aware, these key decisions were announced at the end of the three month period that was set aside to consider the report. The third phase of the Government’s response to the Royal Commission’s report consists of our detailed decisions on each of the 49 recommendations. I announced these in the middle of this month. There is considerable detail here so I’ll summarise them in groups. The full detail can be found on my, and the Ministry for the Environment’s, websites.

Before doing that, I’ll just make one important point. Our decisions on a recommendation sometimes refer to accepting the “intention of the recommendation”. The Commission’s report was silent in some cases on how to implement its recommendations, and in working through this we have decided to accept the intention underlying the recommendation or accepted the recommendation “in principle”, rather than accept its actual wording. This will mean that some of these intentions are carried out in different ways, a matter of scientific or legal practicality.

So for example, there’s been some interest in our response to recommendation 7.5 which says, “that, wherever possible, non-food animals, or animals less likely to find their way into the food chain, be used as bioreactors rather than animals that are a common source of food.” The Government has accepted the intent underlying this recommendation, which is to ensure that GM animals and animal products not to enter the food chain unintentionally. We think that given the strict controls placed on contained research, including field testing, the additional measures that will be put in place, and New Zealand’s strict food regulations there is sufficient protection against GM animals escaping from containment and finding their way into the food chain.

So let’s look at these detailed decisions on the 49 recommendations:

- Research and controls in containment: 12 of the Royal Commission’s recommendations aim to simplify the approval process for low-risk laboratory based GM research, without changing the scope of the low-risk research that can be permitted. We’ve accepted all of these recommendations, or in some cases, as I have described, the intent behind them. Two recommendations pick up gaps in the HSNO Act’s coverage. We’ve instructed officials to undertake further policy work to determine the most appropriate mechanism to resolve the gaps in regulation of GM cell lines and tissue cultures. Finally we’ve agreed that Institutional Biological Safety Committees (or IBSCs, which do much of the routine work in approving low risk laboratory experiments), should have appropriate Maori input in decision-making, that GM animals and animal products do not find their way into the food chain unintentionally (I referred to this earlier), and that the Bioethics Council address ethical issues raised by the use of human genes in transgenic mammals.

- Conditional release and investigation into co-existence: 13 of the Commission’s recommendations fall into this area, covering a proposed new category of approval called “conditional release”, co-existence between GM and non-GM crops and the need for further research. The policy work that will proceed in this area is substantive and links to our decisions to constrain, for a period, applications for release.

Can I just say here, no decisions have been made or positions taken by the Government on the possibility or the desirability of co-existence between GM and non GM-crops. It is premature to make this decision now, and we need to await the results of current and new research over the next two years. What we have agreed is that policy work on co-existence be progressed in the absence of any actual applications for release. This policy work and its research also will inform future decisions about the possibility or desirability of GM crop releases and co-existence.

- Food and medical: The 10 recommendations that relate to food and medical issues, have all been accepted to varying degrees. We’ve agreed to monitor research on stock feed, to scope the development of a voluntary GM-free label for GM-free foods, and to disseminate information on GM food and the labelling regime for GM food that comes into force early next month. We’ve also agreed that work progress to clarify and streamline the food and medicines interface and that there be appropriate ethical oversight of modern genetic technology applications in the medical field.

- Intellectual property: We’ve accepted all of the seven recommendations relating to intellectual property. Much of the policy work in this area will be picked up in the next stage of the review of the Patents Act. We’ve also directed officials to consult with stakeholders on the appropriate level of protection for sensitive information under the HSNO Act and Agricultural Compounds and Veterinary Medicines Act.

- Overarching and structural elements.: I’ve already commented on some of the decisions made on the 7 recommendations that fall into this group. In addition to those decisions, we’ve agreed that the HSNO Act be amended so that it more appropriately reflects the Treaty of Waitangi relationship. We’re currently in the process of appointing a Maori Reference Group to assist in addressing this. My discretionary call-in powers under the HSNO Act will be amended to include significant cultural ethical and spiritual effects as grounds to call in an application.

Compliance costs

At the beginning of my speech, I said I was going to focus on two matters. I’d like to turn now to look at the second of those: the compliance cost implications of the Government’s decisions.

Field testing: To a large extent, the changes on controls for approved field tests are putting in law what is already currently ERMA practice. So the changes should not affect the compliance costs of research work significantly, and arguably give scientists more certainty. The streamlining of the low risk regulations will reduce compliance costs for low risk research.

I have heard the cries from some quarters that compliance costs under the HSNO Act are too high. This Government is committed to efficient laws and seeks to minimise compliance costs - but without compromising the purpose of the laws. In the case of genetic modification, we are dealing with an issue that has uncertainties and has high public interest. Genetic modification vividly highlights the interface between science and society - genetic modification tests peoples’ trust in science and our institutions. The upcoming law changes offer assurances that the potential risks are strictly managed and minimised.

Balancing the potential benefits to be obtained from GM technology while making sure that we preserve our environmental health and safety does come at a cost. I make no apologies for that.

The reality is that the cost is shared between the community and those doing the work. The Government subsidises about 50% of the application process under ERMA. In particular, the costs of public participation are largely met by the Crown’s funding to the Authority.

Conclusions

So where does this leave us in managing genetic modification? Let me summarise:

- The Government supports the overall strategy of preserving opportunities as recommended by the Royal Commission. This decision is based on ensuring the health and safety of all New Zealanders and their environment, and it is a cautionary approach.

- Our decision is a balanced one. It means that extra steps will be taken to protect our health and environment, but it also recognises the need to have knowledge and innovation drive our future as a nation.

- Applications to release GMOs will not go ahead for two years - unless they offer important human and animal health benefits.

- Controls on contained research will be enhanced.

- The work over the next two years will give us information about social, economic and environmental impacts of GMOs, it will explore policy options for the future, and further changes will be made to the HSNO Act to enhance it.

Throughout the next two years while this work is developing, there will be many opportunities for you to participate in making the system better. I hope that those of you with interest in this area will continue to keep informed and involved in this very important issue.

Let me conclude by reminding you that my goal for the environment is to make our clean and green image a reality. This includes creating and implementing a sustainable and long-term strategy for New Zealand’s approach to genetic modification. It means ensuring that our management of genetic modification gets the balance right. It would be arrogant to shut our eyes to this technology, genetic modification has been happening (in containment) in New Zealand for the last 13 years. As a country dependent on our biological production systems (farms forests and fishing to name but a few) we need to keep up with and understand the science in this critical area.

It also means utilising genetic modification where the benefits are clear. This is already happening in the health field - for example insulin for the treatment of diabetes is derived from genetic modification - and it may happen for the environment. The most well known genetic modification research that may help us manage the New Zealand’s environment involves fertility control for possums. This work is all in containment of course. Landcare Research is investigating the possibility of such control, which may result in environmental benefits in terms of reduced use of poisons such as 1080 and reduction in damage to forests by possums. There are also associated benefits in controlling the spread of bovine tuberculosis, which is carried by possums, affecting our cattle and deer herds. However, such benefits, if they eventuate, are a long way off.

At the same time we are determined to minimise the risks to people and the natural environment. We want to protect New Zealand’s indigenous plants and animals, and we want to ensure that farmers, including organic farmers, are able to choose what production systems they use.

When it comes right down to it, this does mean proceeding with caution and this is exactly what the Government is doing.

ENDS

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